Surgical device with tandem fasteners

ABSTRACT

A surgical fastener applier having a handle and a fastener housing extending from the handle. The housing contains at least one anvil movable within the staple housing, the anvil has a proximal position and a distal position. When in the distal position a distal end of the anvil extends distal to the distal end of the staple housing. The housing contains a plurality of surgical fasteners each of which in the shape of a loop. At least one of the fasteners is placed around a portion of the anvil when in the distal position. The applier has a first mechanism for moving the anvil distally after a fastener has been deployed, and a second mechanism for moving the anvil distally after a fastener has been deployed. The second means is independent of the first means.

RELATED APPLICATIONS

This application is a Continuation (“CNT”) of U.S. application Ser. No.15/626,550 filed Jun. 19, 2017, which is a Continuation (“CNT”) of U.S.application Ser. No. 13/911,337 filed Jun. 6, 2013, now U.S. Pat. No.9,713,471, which is a Continuation in Part (“CIP”) of U.S. applicationSer. No. 13/371,684 filed Feb. 13, 2012, now abandoned, which is a CIPof U.S. application Ser. No. 13/371,678 filed Feb. 13, 2012, nowabandoned, which is a CIP of U.S. application Ser. No. 13/362,172 filedJan. 31, 2012, now abandoned, which is a CIP of U.S. application Ser.No. 13/164,949 filed Jun. 21, 2011, now abandoned, which is a CIP ofU.S. application Ser. No. 13/164,963 filed Jun. 21, 2011, now abandoned,which is a CIP of U.S. application Ser. No. 13/164,954 filed Jun. 21,2011, now abandoned, which is a CIP of U.S. application Ser. No.13/015,966 filed Jan. 28, 2011, now U.S. Pat. No. 8,469,252, which is aCIP of U.S. application Ser. No. 12/690,285 filed Jan. 20, 2010, nowU.S. Pat. No. 8,602,286, which is a CIP of U.S. application Ser. No.12/608,860 filed Oct. 29, 2009, now U.S. Pat. No. 9,713,468, which is aCIP of U.S. application Ser. No. 12/359,351 filed Jan. 26, 2009, nowabandoned, which is a CIP of U.S. application Ser. No. 12/359,357 filedJan. 26, 2009, now U.S. Pat. No. 8,801,732. The complete disclosures ofthe aforementioned related U.S. patent applications are herebyincorporated herein by reference for all purposes.

FIELD OF THE INVENTION

The present invention relates in general to the joining of cavity walltissue with a surgical stapler and, more particularly, to a low profilestapler for delivering multiple large-sized box staples to a body cavitythrough a small delivery port. The low profile stapler enables largeareas of tissue to be joined together inside a body cavity through asmall access port.

BACKGROUND OF THE INVENTION

Obesity is a medical condition affecting more than 30% of the populationin the United States. Obesity affects an individual's quality of lifeand contributes significantly to morbidity and mortality. Obesity ismost commonly defined by body mass index (BMI),

a measure which takes into account a person's weight and height to gaugetotal body fat. It is a simple, rapid, and inexpensive measure thatcorrelates both with morbidity and mortality. Overweight is defined as aBMI of 25 to 29.9 kg/m2 and obesity as a BMI of 30 kg/m2. Morbid obesityis defined as BMI≥40 kg/m2 or being 100 lbs. overweight. Obesity and itsco-morbidities are estimated to cost an excess of $100 billion dollarsannually in direct and indirect health care costs. Among the co-morbidconditions which have been associated with obesity are type 2 diabetesmellitus, cardiovascular disease, hypertension, dyslipidemias,gastroesophageal reflux disease, obstructive sleep apnea, urinaryincontinence, infertility, osteoarthritis of the weight-bearing joints,and some cancers. These complications can affect all systems of thebody, and dispel the misconception that obesity is merely a cosmeticproblem. Studies have shown that conservative treatment with diet andexercise alone may be ineffective for reducing excess body weight inmany patients.

A surgical procedure has been developed for involuting the gastriccavity wall to reduce stomach volume as a treatment for obesity. In thegastric volume reduction (GVR) procedure (e.g., reduction gastroplasty,gastric plication, greater curvature plication, anterior surfaceplication, etc.), multiple pairs of suture anchoring devices, such asT-Tag anchors, are deployed through the gastric cavity wall. Preferably,the suture anchors are deployed through a small diameter port in aminimally invasive surgical procedure to reduce trauma to the patient.Following deployment of the T-Tag anchors, the suture attached to eachindividual pair of anchors is cinched to approximate the tissue andsecured to involute the cavity wall between the anchors. This procedureis described in greater detail in co-pending U.S. patent applicationSer. Nos. 11/779,314, 11/779,322, 12/113,829, 12/179,600, 12/359,351,12/609,336, and 12/690,311, which are hereby incorporated herein byreference in their entirety. Procedure variations of particular interestinclude the case where the involution occurs about the midline of theanterior surface of the stomach, the case where the involution occursabout the greater curvature of the stomach following the removal orrelaxing of attachment points along the greater curve (e.g., dissectionof the short gastric vessels, dissection of the omentum from the gastricwall, etc.), and combinations of these (e.g., the involution begins nearthe gastroesophageal junction and extends about the greater curve andtransitions to the anterior surface near the incisura angularis).Preclinical outcomes around fastener durability for gastric plicationprocedures in a canine model are discussed in Menchaca et al. “Gastricplication: preclinical study of durability of serosa-to-serosaapposition”. Surg Obes Relat Dis 2011; 7:8-14. Clinical outcomesdiscussing different gastric plication procedures are discussed inBrethauer et al. “Laparoscopic gastric plication for the treatment ofsevere obesity”. Surg Obes Relat Dis 2011; 7:15-22. One effect of theprocedure is to more rapidly induce feelings of satiation defined hereinas achieving a level of fullness during a meal that helps regulate theamount of food consumed. Another effect of this procedure is to prolongthe effect of satiety which is defined herein as delaying the onset ofhunger after a meal which in turn regulates the frequency of eating. Byway of a non-limiting list of examples, positive impacts on satiationand satiety may be achieved by a GVR procedure through one or more ofthe following mechanisms: reduction of stomach capacity, rapidengagement of stretch receptors, alterations in gastric motility,pressure induced alteration in gut hormone levels, and alterations tothe flow of food either into or out of the stomach. As an example, astomach with a reduced capacity will distend more quickly for a givenvolume of food. This distension of the stomach may trigger stretchreceptors which in turn trigger a sense of satiation. In anotherexample, the procedure will limit the stomach's ability to expand,effectively reducing its capacity or fill volume. Additionally, theprocedure may induce a beneficial hormonal effect due either to the morerapid triggering of stretch receptors in certain regions of the stomachor the prevention of hormone release by eliminating triggeringmechanisms from being engaged in the infolded region that no longerexperiences stretch in the same manner. In yet another example, theprocedure may alter gastric emptying by preventing efficient antralcontractions. Additionally, the infolded region may provide arestrictive inlet into the stomach just distal to the esophagogastricjunction. The GVR procedures described in these applications requireindividual placement of each suture anchor pair into the cavity walltissue, and subsequent tensioning of the suture between the anchor pairsin order to involute the tissue. This individual placement of the T-Taganchors and manual suture tensioning is time intensive; increasing theduration, complexity and cost of the GVR procedure. Accordingly, it isdesirable to have a simpler, faster, and less expensive means forforming a tissue fold within the peritoneal cavity.

It is known to use surgical staples for binding and holding body tissuestogether following an anastomosis, skin closure, or other surgicalprocedure. Traditionally, these staples have had a wide U-shape in theundeformed state, requiring a large incision site or wide diametertrocar cannula to accommodate the staples and stapler. Staples andstaplers having a lower profile have been developed for use in smallerdiameter (i.e. 5 mm or 10 mm) trocars. However, these devices sufferfrom a number of deficiencies which make them impractical for use in theGVR procedure. In particular, such staplers require bending the staple afull 180° from the predeployment, stacked condition in the stapler tothe closed, deployed condition in the tissue. Obtaining this degree ofplastic deformation requires that the staple be composed of a soft,ductile material, such as soft titanium. However, the use of a softductile material decreases the strength and holding power of the formedstaple, thus making the staple unsuitable for the pressures associatedwith involuting the gastric cavity wall without an impractical number ofstaples. Staples having a triangular prefiring configuration have alsobeen developed for deployment through a low profile stapler. However,the triangular shape of these staples prevents the staples from beingstacked and fed longitudinally through the stapler shaft. Instead, thestaples are stacked and fed vertically within the stapler, which reducesthe number of staples that can be deployed from the stapler while stillmaintaining a low profile diameter. Since some versions of the GVRprocedure may require a large number of staples to involute the cavitywall, vertical stacking would necessitate using more than one stapler tocomplete a procedure. Additionally, previous staplers have bent staplesat three or fewer points during formation and deployment, which reducesthe amount of work hardening and, thus, strengthening within the formedstaple.

Accordingly, to facilitate GVR and other surgical procedures, it isdesirable to have an improved surgical staple and deploying stapler forfastening layers of tissue within the peritoneal cavity. It is desirablethat the stapler has a low profile for use through a small diameterlaparoscopic port, a single trocar containing multiple smalllaparoscopic ports, or through a semi-rigid or flexible endoscopicplatform (e.g., for use in natural orifice surgical procedures), yet becapable of deploying staples with a large tissue purchase. Further, itis desirable that the staples have a folded, box shape, and that a largequantity of the staples be deliverable by a single stapler during aprocedure. Additionally, it is desirable to have a stapler which altersthe configuration of a staple from a low profile, reduced width prior todeployment to a wider, operable width following deployment. The presentinvention provides a surgical staple and stapler which achieves theseobjectives.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an isometric view of an exemplary low profile surgical staplerof the present invention;

FIG. 2 is a top view of an exemplary staple embodiment shown in aninitial, undeployed condition;

FIG. 3 is a top view of the staple of FIG. 2 shown in an intermediatedeployment condition;

FIG. 4 is a top view of the staple of FIG. 2 shown in a final, deployedcondition;

FIG. 5 is an exploded isometric view of the staple housing and deployingassembly for the stapler of FIG. 1 ;

FIG. 6 is an exploded isometric view, partially in section, of theformer, shoe and staple housing of FIG. 5 ;

FIG. 7 is a side, partially sectional view of the distal end of thestapler handle;

FIG. 8 is an isometric view of the stapler of FIG. 1 , shown with aportion of the left side of the handle casing detached;

FIG. 9 is an exploded isometric view of the stapler of FIG. 8 shown withthe left side of the handle casing removed;

FIG. 10 is an exploded isometric view of the right side of the stapler,showing a number of handle components, viewed from the lower proximalend of the stapler;

FIG. 11 is a more detailed, isometric view of the right side of theclamp yoke shown in FIG. 10 ;

FIG. 12 is a side, partially sectional view of the distal end and handleof the stapler showing an initial deployment condition;

FIG. 13 is a side, partially sectional view of the distal end of thestapler showing the staple deploying assembly in an initial deploymentcondition;

FIG. 14 is a right side view of the proximal end of the stapler in aninitial deployment condition, shown with the outer cover removed;

FIG. 15 is a side, partially sectional view of the distal end and handleof the stapler showing the actuator lobes pivoted distally to releasethe anvil latch;

FIG. 16 is a side, partially sectional view showing the distal end ofthe stapler in the same deployment condition as FIG. 15 , with the anvilretracted proximally against the clamp;

FIG. 17 is a right side view of the proximal end of the stapler with theouter cover removed, showing the same deployment condition as FIG. 15 ;

FIG. 18 is a side, partially sectional view of the distal end and handleof the stapler showing the former, anvil and clamp in a proximal-mostposition;

FIG. 19 is a side, partially sectional view showing the distal end ofthe stapler in the same deployment condition as FIG. 18 , with a stagedstaple being deposited into the discharge channel;

FIG. 20 is a right side view of the proximal end of the stapler with theouter cover removed, showing the same deployment condition as FIG. 18 ;

FIG. 21 is a side, partially sectional view of the distal end and handleof the stapler showing a deployment condition in which the actuatoradvances the clamp distally;

FIG. 22 is a side, partially sectional view showing the distal end ofthe stapler in the same deployment condition as FIG. 21 , with the clampcontacting the back span of a staged staple;

FIG. 23 is a right side view of the proximal end of the stapler with theouter cover removed, showing the same deployment condition as FIG. 21 ;

FIG. 24 is a side, partially sectional view of the distal end and handleof the stapler showing a deployment condition in which the actuatoradvances the clamp and anvil distally;

FIG. 25 is a side, partially sectional view showing the distal end ofthe stapler in the same deployment condition as FIG. 24 , with the clamppushing the staged staple and anvil distally through the deploymentopening;

FIG. 26 is a right side view of the proximal end of the stapler with theouter cover removed, showing the same deployment condition as FIG. 24 ;

FIG. 27 is a side, partially sectional view of the distal end and handleof the stapler showing a deployment condition in which the clamp andanvil are locked in a fully distal position;

FIG. 28 is a side, partially sectional view showing the distal end ofthe stapler in the same deployment condition as FIG. 27 , with the fullydistal clamp and anvil opening the staple outside the distal deploymentopening;

FIG. 29 is a right side view of the proximal end of the stapler with theouter cover removed, showing the same deployment condition as FIG. 27 ;

FIG. 30 is a side, partially sectional view of the distal end and handleof the stapler showing a deployment condition in which the actuator isreleased open during a pause in the deployment sequence;

FIG. 31 is a side, partially sectional view showing the distal end ofthe stapler in the same deployment condition as FIG. 30 , with the fullydistal clamp and anvil holding the open staple outside the distaldeployment opening;

FIG. 32 is a right side view of the proximal end of the stapler with theouter cover removed, showing the same deployment condition as FIG. 30 ;

FIG. 33 is a side, partially sectional view of the distal end and handleof the stapler showing a deployment condition in which the actuator isre-closing and pushing the former distally;

FIG. 34 is a side, partially sectional view showing the distal end ofthe stapler in the same deployment condition as FIG. 33 , with theformer advancing to close the staple outside the distal deploymentopening;

FIG. 35 is a right side view of the proximal end of the stapler with theouter cover removed, showing the same deployment condition as FIG. 33 ;

FIG. 36 is a side, partially sectional view of the distal end and handleof the stapler showing a deployment condition in which the actuatorpivots open to draw the former and clamp back proximally from the closedstaple;

FIG. 37 is a side, partially sectional view showing the distal end ofthe stapler in the same deployment condition as FIG. 36 , with the clampand former drawn back proximally from the closed staple; and

FIG. 38 is a right side view of the proximal end of the stapler with theouter cover removed, showing the same deployment condition as FIG. 36 .

FIG. 39 is a photomicrograph at 8 weeks of a distal (pyloric) portion ofa plication site from a canine model.

FIG. 40 is a histologic image of single row of suture at greatercurvature. In regions of fold not containing fasteners, serosal surfacesdid not bond.

FIG. 41 is a photomicrograph at 8 weeks of a proximal (esophageal)portion of a plication site from a canine model.

DETAILED DESCRIPTION OF THE INVENTION

Referring now to the drawing figures, in which like numerals indicatelike elements throughout the views, FIG. 1 illustrates an exemplary lowprofile surgical stapler for use in GVR and other small incision siteprocedures in the peritoneal cavity including, but not limited to,reinforcement of staple lines (e.g., “oversewing” of a vertical sleevegastrectomy), closing of surgical defects (e.g., gastrotomy closure),and fixation of temporary (e.g., liver retraction) or permanent (e.g.,hernia mesh, gastric band securement) medical devices. As shown in FIG.1 , the stapler 10 includes a handle 12 having a pistol grip 14 shapedfor grasping by a surgeon. An actuator 16 is movably coupled to handle12 to be drawn towards the pistol grip 14 during staple deployment. Anelongated staple housing 20 having a longitudinal axis extends distallyfrom handle 12. Housing 20 has sufficient length (on the order of 18″)to enable use within an obese patient at numerous trocar access sitesfor traditional laparoscopic approaches. Likewise, housing 20 is sizedto allow for passage through a small (3-5 mm) diameter trocar, althoughfunctional devices of a larger diameter are also possible withoutdeparting from the overall scope of the invention. A staple deployingassembly is at least partially disposed within the interior of housing20 for discharging staples from a distal deployment opening 22. Staplesare individually advanced outside of the open stapler end 22, andexpanded open through actuation of the handle. After the staple piercesor otherwise engages the tissue sections to be joined, the stapler drawsthe expanded staple legs back inward to close the staple through thetissue.

To obtain a large tissue purchase (which is desirable in GVR procedures)while using a small diameter delivery shaft, stapler 10 deploysfasteners or staples having a folded, closed loop configuration. Theseclosed loop or “box” staples have a small width in the initial, unformedcondition. The width of the staple is expanded during opening andforming to allow the staple to obtain a large tissue purchase. FIG. 2illustrates an exemplary box staple 30 for deployment from stapler 10.Staple 30 comprises a length of wire formed into a crown or back span 32and first and second leg portions 34, 36 that intersect with oppositeends of the back span. The wire has a cylindrical cross-section, but mayhave other shapes (e.g., rectangular, elliptical, etc.) to provideoptimal strength for the application or to aid in the feeding of thestaples, and may or may not be uniform along the length of the wire. Legportions 34, 36 intersect with back span 32 at an approximate angle α of90° and extend in a substantially parallel fashion forward of the backspan. Opposite back span 32, leg portions 34, 36 are bent inward to formstaple end segments 40, 42. In a loop shape, two lengths of wire may bedisposed across one side of the shape to enclose the shape, asdemonstrated by the end segments 40, 42. Staple legs portions 34, 36 arebent at end segments 40, 42 to make one of the leg portions at least onewire diameter longer in length than the other leg portion. The longerlength of one leg portion (i.e. staple leg 34 in FIG. 2 ) enables theend segments 40, 42 to lie in a common plane with back span 32. The tipsof end segments 40, 42 are angled to form sharp prongs 46 for piercingtissue.

FIG. 3 shows staple 30 in a second, intermediate deploying condition. Inthis intermediate state, staple legs portions 34, 36 are bent outward todescribe a maximum width between the distal tips of the staple legs. InFIG. 3 , staple legs 34, 36 are shown expanded open approximately 180°into substantially lateral alignment with the initial back spanposition, with end segments 40, 42 projecting distally. However, itshould be understood that staple legs 34, 36 can be expanded open to anangle less than or greater than 180°. Staple legs 34, 36 are bentoutward by applying a deploying force (indicated by arrow 38 in FIG. 2 )to a mid section of back span 32 while the staple is held fixed insideat the intersections between the staple legs and back span. Theapplication of force 38 against the opposite, fixed forces at the stapleleg intersections pulls the staple legs 34, 36 outward, expanding openthe staple, while substantially simultaneously indenting the center ofthe back span 32. As staple legs 34, 36 are bent outward, back span 32retains a non-linear characteristic. The outward bending of staple legs34, 36 creates an enlarged opening into the staple 30 that is preferablyin the range of twice the width of the stapler housing. Without a lossin generality, the width may be adjusted for different applications. Asan example, the width may be smaller for applications such as meshfixation.

Staple 30 is transformed to a third, fully deployed form, shown in FIG.4 , by the application of force to laterally spaced points along staplelegs 34, 36. This force application is indicated by arrows 44 in FIG. 3. In the final deployment condition, staple leg portions 34, 36 aredrawn back towards the center of the staple, with prongs 46 againpointing inward through the intervening tissue to penetrate and hold thetissue. The length of staple 30 decreases between the initial and finaldeployment conditions, with an ensuing increase in the staple width, sothat the final width dimension of the formed staple (described by thedistance between staple legs 34, 36) is greater than the initial widthdimension. During deployment, staple 30 transitions between the initial,intermediate, and final formed conditions in a series of steps which maybe substantially simultaneous, but which are preferably carried outsequentially, so as to first open staple 30 to the intermediatecondition of FIG. 3 , and then bend each of the staple legs 34, 36 backaround into the formed condition shown in FIG. 4 . Staples used in thisapplication are preferably biocompatible, implantable, and mayoptionally be absorbable. A non-limiting list of candidate materialsincludes: metals such as titanium and its numerous alloys, stainlesssteel, nitinol, magnesium, and iron; plastics such as PEEK, Prolene™;absorbable materials such as PDS™, Vicryl™, and polylactic acid (PLA);and combinations of these classes of materials. Further, these fastenersmay contain therapeutic agents that are selectively or immediatelyreleased over time to aid in healing, prevent infection (e.g.,triclosan), reduce swelling or edema, etc.

The staple shown in FIGS. 2-4 is intended to be one non-limiting exampleof a closed-form staple with substantially parallel legs. Additionaldetail regarding staple designs, as well as staple applicators,procedure applications, and methods of use are disclosed in co-pendingU.S. patent application Ser. No. 12/359,351 filed Jan. 26, 2009 entitled“A SURGICAL STAPLER FOR APPLYING A LARGE STAPLE THROUGH A SMALL DELIVERYPORT AND A METHOD OF USING THE STAPLER TO SECURE A TISSUE FOLD”,co-pending U.S. patent application Ser. No. 12/359,354 filed Jan. 26,2009, entitled “A SURGICAL STAPLER FOR APPLYING A LARGE STAPLE THROUGH ASMALL DELIVERY PORT AND A METHOD OF USING THE STAPLER TO SECURE A TISSUEFOLD”, co-pending U.S. patent application Ser. No. 12/359,357 filed Jan.26, 2009 entitled “A SURGICAL STAPLER FOR APPLYING A LARGE STAPLETHROUGH A SMALL DELIVERY PORT AND A METHOD OF USING THE STAPLER TOSECURE A TISSUE FOLD”, co-pending U.S. patent application Ser. No.12/608,860 filed Oct. 29, 2009, entitled “BOX STAPLE METHOD WHILEKEEPING SAID BACK SPAN IN SUBSTANTIALLY ITS ORIGINAL SIZE AND SHAPE”,co-pending U.S. patent application Ser. No. 12/609,336 filed Oct. 30,2009, entitled “A METHOD FOR APPLYING A SURGICAL STAPLE”, and co-pendingU.S. patent application Ser. No. 12/690,311 filed Jan. 20, 2010 entitled“METHOD FOR FEEDING STAPLES IN A LOW PROFILE SURGICAL STAPLER”, whichare hereby incorporated herein by reference in their entirety. Inapplying the staple designs disclosed in the cited US Patentapplications to the present invention, the staple designs wouldpreferably include a non-linear back span. In addition to the stapledesigns disclosed herein, it is anticipated that other alternativestaple designs may also be conceived and used with the present inventionwithout departing from the scope of the invention.

Turning now to FIG. 5 , which shows an exemplary staple deployingassembly for deploying staples 30 in accordance with the invention. Asshown in FIG. 5 , stapler 10 includes a staple former 50 attached to thedistal end of staple housing 20 for forming and closing staples. Stapledeployment opening 22 is located at the distal end of former 50. Former50 includes an inner channel (not shown) for conveying staples throughthe former and outside the stapler during deployment. Staples 30 areindividually conveyed through former 50 and distal opening 22 by ananvil 52. Anvil 52 includes a pair of longitudinally extending, inwardlybiased spring arms having upwardly curved, staple holding tines 56 atthe distal end. The proximal face of each anvil tine 56 is preferablyrounded with an inward radius to aid in positioning and retaining astaple on the tines during deployment. Individual staples are heldagainst the anvil tines during passage through the former 50. Theproximal end of anvil 52 is shaped for connecting the anvil to an anvilextension 54. Anvil extension 54 extends proximally from anvil 52,through housing 20, and inside handle 12.

A staple clamp 60 extends substantially along the surface of anvil 52.Clamp 60 comprises an elongated strip having substantially planar upperand lower surfaces and a width slightly narrower than the width of theunformed staples 30. Clamp 60 preferably has as small a length asnecessary to cover the anvil 52. The distal end of clamp 60 is shapedfor mating engagement with staple back span 32 for engaging and pushingthe staple through former 50. The distal end of clamp 60 is angledinwardly to a center tip at approximately a 45° angle relative to thelongitudinal stapler axis, although lesser or greater angles may be usedto vary the opening size of the staple. The angled clamp tip includes aninward radius for mating against the outer circumference of the stapleback span 32. Anvil 52 combines with the distal face of clamp 60 andformer 50 to form the discharge channel of the staple deployingassembly. During the deployment sequence, clamp 60 advances distallywithin the discharge channel to deform the back span of a staged stapleand thereby open the staple.

The proximal end of clamp 60 is attached to a driving assembly in handle12 via a clamp extension. The clamp extension includes an upper section64 and a lower section 66. Upper clamp extension 64 comprises anelongated, planar strip supporting a staple stack 70. Alongitudinally-extending trough 72 is located midway across the width ofupper extension 64, beneath staple stack 70, and extends from the distalend beyond the proximal end of the staple stack. Lower clamp extension66 has an elongated, grooved surface to accommodate trough 72. A stapledriving member comprising a substantially rigid, cylindrical rod 74 isretained within trough 72 in a spaced relationship from the plane ofstaple stack 70. A plurality of outwardly projecting staple advancers 76are evenly spaced apart substantially along the length of rod 74. Stapleadvancers 76 extend to at least the proximal end of staple stack 70 toensure that a staple advancer engages the proximal-most staple in thestack. The proximal end of staple driving rod 74 is curved atapproximately a 90° angle relative to the longitudinal rod axis to forma control pin 80.

Rod 74 is retained within trough 72 so as to translate distally and thenback proximally with the clamp extension during each staple deployment.Additionally, rod 74 rotates within trough 72 about the longitudinal rodaxis. Upper clamp extension 64 includes a plurality of notches spacedapart along a side of trough 72. The notches are aligned with stapleadvancers 76 to allow the advancers on rod 74 to rotate out of trough 72and above the surface of the clamp extension. The distal end of rod 74extends through an open distal end of trough 72 into clamp 60. Thestaple advancer at the distal end of rod 74 is located in a groove inthe proximal end of clamp 60. Rod 74 rotates relative to clamp 60, withthe distal-most staple advancer extending up through a notch in theclamp. Rod 74 and the attached staple advancers 76 are advanced andretracted by the clamp extension to index staple stack 70 distallyapproximately one staple length during each staple deployment.

A staple guide 82 is located proximal of former 50 inside staple housing20. The outer perimeter of staple guide 82 is shaped to conform to theinner circumference of staple housing 20 to enable the staple guide toextend concentrically within the staple housing. Staple guide 82 isfixed at a proximal end within the stapler handle 12 by a key 78 toprevent translation of the guide along the longitudinal housing axisduring staple deployment. Distal housing bushing 106, into which key 78extends, includes two notches 108 located 180 degrees apart on thecircumference of bushing 106 to permit the staple guide 82 to rotatewith staple housing 20 about the longitudinal housing axis forpositioning the staple prongs 46. A slot 87 is formed in staple housing20 adjacent guide key 78. Guide key 78 extends up through slot 87 toallow staple housing 20 to translate along the longitudinal housing axisrelative to the fixed staple guide 82.

Staple guide 82 includes a plurality of flexible, longitudinally-spacedanti-backup arms 83 (shown in FIG. 13 ) extending in the direction ofstaple stack 70. The anti-backup arms flex in and out of contact withthe staples in stack 70 to prevent the stack from moving proximallywithin the staple housing during the staple deployment sequence.Proximal of the anti-backup arms, a closed, contoured guide path (notshown) is formed into the surface of staple guide 82 facing control pin80. Control pin 80 extends into and rides along the guide path totranslate staple driving rod 74 relative to the fixed staple guide 82.While control pin 80 transverses the guide path, the angular directionof the pin changes. The directional changes of control pin 80 rotate rod74 within trough 72. As rod 74 rotates, staple advancers 76 are rotatedfrom a position inside trough 74 to a position above the surface planeof upper clamp extension 64. Above clamp extension 64, the stapleadvancers 76 rotate up into the closed loops of the staples in stack 70.The guide path includes a forward track, in which control pin 80 pivotsto rotate stapler advancers 76 up inside the loops of staples 30 toadvance the staple stack; and a return track, in which control pin 80pivots to rotate the staple advancers down into trough 72 to allow thestaple advancers to retract beneath the advanced staple stack, back tothe initial position.

Staple stack 70 extends longitudinally through housing 20, betweenstaple guide 82 and clamp extension 64, in a plane parallel to thelongitudinal axis of the housing. Staples 30 are conveyed within stack70 to the distal end of the stapler prior to deployment. Within stack70, each staple 30 is oriented such that the abutting end segments 40,42 of the staple are positioned nearest the open stapler end 22. Withinthe staple stack, staples may be spaced apart from other staples, incontact with other staples, or alternate between states of contact andspaced. The legs 34, 36 of each staple 30 are aligned substantiallyparallel to and may be in contact with the walls of staple guide 82 tomaintain the forward orientation of the staples. Any number of staples30 can be included within stack 70, with the preferred staplerembodiment capable of holding 20 or more staples to facilitateprocedures, such as GVR, which require a large number of tissueappositions or junctions. The distal end of staple stack 70 is conveyedalong the surface of clamp 60 prior to the dropping of the individualstaples onto anvil 52 for deployment.

Staple stack 70 is adjacent to the inner surface of staple guide 82 toenable the anti-backup arms 83 to contact the staples within the stack.As shown in FIGS. 5 and 6 , a staple transporter or shoe 84 extends fromthe distal end of staple guide 82 into former 50 for transferringstaples from stack 70 onto anvil 52. Shoe 84 is cantilevered betweenstaple guide 82 and former 50 with the pivot point at the proximal endwithin the staple guide. The distal end of shoe 84 flexes to index asingle, distal-most staple in stack 70 from the surface of clamp 60 intoa staging position on anvil 52 during each deployment sequence. Theproximal end of shoe 84 is shaped to facilitate movement of staplesbeneath the shoe as the stack 70 is advanced through housing 20 beneathstaple guide 82. The staple advancer 76 at the distal end of stapledriving rod 74 pushes the next staple in the stack 70 under shoe 84during each deployment cycle. Shoe 84 includes a C-channel, indicated at86, through which the distal end of staple stack 70 passes. The lowersides of C-channel 86 are co-planar with the staple conveying surface ofclamp 60 to pass the staple stack 70 through the channel as the stack isadvanced along the surface of the clamp. C-channel 86 aids inmaintaining staple alignment at the distal end of stack 70, and preventsthe distal-most staple in the stack from prematurely tilting into thedischarge channel during retraction of clamp 60.

During the staple deployment process, clamp 60 moves distally throughthe discharge channel, advancing against the back span of a staple 30,and pinning the staple between the distal clamp tip and anvil tines. Asclamp 60 advances, the distal end of shoe 84 flexes up against adownward bias by the contact between the advancing clamp and theproximal sloped surfaces of shoe side rails 88. As the distal-moststaple moves underneath shoe side rails 88, the side rails push thestaple legs 34, 36 down onto clamp 60. The staple remains in thisposition, between shoe 84 and clamp 60, and against the proximal face offormer 50, during the opening and forming of the previous staple. Whenclamp 60 retracts following staple forming, shoe 84 pushes the stapledownward into the discharge channel between the distal clamp face andretracting anvil tines, thereby staging the staple for the nextdeployment sequence. In the present invention, the staple deployingcomponents within housing 20 are substantially the same size as thepre-deployment staples 30, in order to maximize the staple size and,thus, tissue purchase during deployment, while maintaining a small (3-5mm) profile for the stapler. The distal deployment opening 22 in former50 is sized to allow clamp 60, anvil 52, and the deploying staple 30 topass outside of the former during the deployment process, while theproximal face of the former serves as an end stop for staple stack 70.Additional details regarding the staple deploying assembly can be foundin U.S. patent application Ser. No. 12/359,351 entitled “A SURGICALSTAPLER FOR APPLYING A LARGE STAPLE THROUGH A SMALL DELIVERY PORT AND AMETHOD OF USING THE STAPLER TO SECURE A TISSUE FOLD” and U.S. patentapplication Ser. No. 12/690,311 entitled “METHOD AND APPARATUS FORFEEDING STAPLES IN A LOW PROFILE SURGICAL STAPLER”, which have beenpreviously incorporated into this application by reference.

In a surgical application, stapler 10 is manipulated through a trocar(in a laparoscopic procedure) or flexible endoscopic platform (innatural orifice, endoluminal or transluminal procedures) so thatdeployment opening 22 is adjacent to the tissue area to be fastened.Staple housing 20 may be rotated relative to handle 12 to change theorientation of deployment opening 22. As shown in FIG. 7 , one manner ofrotating housing 20 is by way of a knob 90 connected about thecircumference of the housing. Knob 90 includes a flange 92 which rotateswithin a slot at the distal end of handle 12. The location of flange 92within the handle slot allows rotation of knob 90 about the longitudinalhousing axis, while preventing the knob from translating along the axis.As knob 90 is rotated, housing 20 is in turn rotated by a connectionbetween the housing and the knob. A connection also exists between knob90 and the staple deploying assembly inside of housing 20 to rotate thedeploying assembly in conjunction with the housing about thelongitudinal housing axis. Accordingly, as housing 20 rotates, the legsof staple 30 rotate relative to the surrounding tissue, thereby alteringthe position at which the staple prongs will pierce the tissue duringdeployment.

As shown in further detail in FIGS. 5 and 7 , staple housing 20 may beformed of two separate sections, identified as 94, 96, joined by aconnecting member, such as a castle nut 100. The distal housing end,identified at 94, has a threaded end which is screwed into the distalend of nut 100. The proximal housing end, identified at 96, also has athreaded end which is screwed into the opposite, proximal end of nut100. One end of nut 100 has right-handed threads while the opposite endhas left-handed threads. The opposite threading allows the two housingsections 94, 96 to be adjustably connected together via the nut 100.Either section 94 or 96 of the staple housing can be rotated relative tonut 100 to increase or decrease the effective longitudinal length of thehousing. Adjusting the length of staple housing 20 during assembly ofthe stapler 10 provides tolerancing for slight manufacturing deviationsthat might otherwise adversely affect the forming and closing of staplesat distal deployment opening 22.

Nut 100 includes a plurality of longitudinally extending grooves 102evenly spaced apart around the outer circumference of the nut. The innercircumference of rotating knob 90 has at least one longitudinallyextending rib (not shown) sized to fit within grooves 102. After staplehousing 20 is adjusted via nut 100 to the proper deployment length, thenut is rotated slightly to align the nearest nut groove 102 with agroove 104 on the exterior of distal housing bushing 106 (shown in FIG.9 ). Knob 90 is then connected over nut 100 and distal housing bushing106, with ribs inside the knob aligned with and engaging groove 102 onnut 100 and groove 104 on bushing 106. The interaction of the knob ribwith the nut and bushing grooves locks the angular position of nut 100,and thereby fixes the longitudinal length of the staple housing 20. Theinterconnection between the knob rib and nut groove also enables theknob to rotate the housing about the longitudinal housing axis asdescribed above. Stapler 10 is depicted as having a rigid housing 20 foropen surgical applications or laparoscopic applications using trocars.However, in alternative embodiments housing 20 may also include at leastone articulation joint allowing the housing to deflect in a controlledmanner from the primary axis, or be substantially flexible and of anincreased length allowing for less invasive, natural orifice (e.g.,transoral, etc.) access to regions of the patient requiring a treatment(e.g., within the peritoneal cavity of the patient). In each of theseconfigurations, it is conceived that the device may also be compatiblewith a single trocar containing multiple ports.

Turning now to FIGS. 8-10 which show the proximal, handle end of stapler10 in an initial deployment position. Handle 12 includes a casing 110comprising an outer cover with an interior molded frame integrallyformed with the cover. Casing 110 may be formed from a plastic or othersimilar material, in sections which are joined together during themanufacturing process by any of a number of suitable means known in theart. The proximal end 96 of staple housing 20 extends into handle 12,through distal bushing 106, and includes a former bushing 112 at theproximal end. A former return spring 114 encircles housing 20 betweenthe distal face of former bushing 112 and the proximal end of distalbushing 106. Staple guide 82 extends proximally through housing 20 intohandle 12. A staple guide stop 116 (shown in FIG. 5 ) is located at theproximal end of staple guide 82. Staple guide stop 116 holds stapleguide 82 stationary with respect to handle 12. Lower clamp extension 66extends proximally into handle 12 through former bushing 112. Theproximal end of lower clamp extension 66 includes a clamp bushing 120. Aclamp return spring 122 surrounds clamp extension 66 between clampbushing 120 and a clamp spring stop 126 (shown in FIG. 12 ).

Clamp bushing 120 is mounted within the frame of a clamp yoke 124. Asshown in greater detail in FIG. 11 , clamp yoke 124 includes a clamplockout member, identified at 128, on a side opposite clamp bushing 120.Clamp lockout member 128 includes a lockout spring 130 which interactswith a lockout tongue 131 on housing casing 110 (shown in FIG. 14 )during the staple deployment sequence. The interaction of lockout spring130 and tongue 131 prevents a stapler jam in the event that actuator 16is fired too quickly. Clamp yoke 124 also includes a proximal clamp stop132 which engages a stop in the handle frame to hold clamp 60 in aproximal-most position. As shown in FIGS. 9-10 , a clamp L-latch 134 islocated beneath yoke 124 and pivots about a pin 136. An L-latch spring138 biases L-latch 134 in the direction of yoke 124.

Anvil extension 54 extends proximally through the open end of housing 20and beyond clamp bushing 120. The proximal end of anvil extension 54includes an anvil stop 140, shown in FIG. 8 , with aproximally-extending anvil release member 142. An anvil spring 144extends between anvil stop 140 and a distal stop, indicated at 146 inFIG. 10 , formed into the frame of handle 12. An opening 150 is locatedin the proximal end of the handle cover for external, operator access toanvil release 142.

Actuator 16 includes a distally facing trigger grip 152 extendingoutside housing casing 110. Opposite trigger grip 152, actuator 16 isdivided into a pair of lobes 154 extending up into the body of handle12. An anvil latching lever 160 is pivotally connected by a pin betweenthe upper ends of lobes 154 to extend proximally from the actuator. Apair of pins 162 extend laterally from the proximal end of anvillatching lever 160 into a cam path 164 shaped into the interior sides ofhandle casing 110. Pins 162 are driven along cam path 164 by the motionof actuator 16. Between pins 162, latching lever 160 includes a flexiblelatching arm 170 having a proximally-extending, tabbed end. A transferwheel 172 having a plurality of outwardly-extending pawls rotates abouta pin adjacent to anvil latching lever 160. In the initial deploymentcondition shown in FIG. 12 , one of the transfer wheel pawls engages thetab at the proximal end of flexible latching arm 170. The contactbetween the latching arm 170 and transfer wheel 172 rotates the wheel asthe latching lever 160 is driven distally along cam path 164. A secondpawl on transfer wheel 172 contacts the distal end of a proximal clamplatch 180. In the initial position shown in FIG. 12 , proximal clamplatch 180 holds clamp yoke 124 in a forward position. A clamp latchspring 182 biases clamp latch 180 down into the locking position. Athird pawl of transfer wheel 172 is positioned adjacent a mating detenton an anvil latch 184. An anvil latch spring 186 is attached to theproximal end of anvil latch 184 to bias the latch into an initiallocking position, in which the latch applies a distal force againstanvil stop 140 to hold the anvil forward against the force of anvilreturn spring 144.

A transfer link 190 is also pivotally connected between the actuatorlobes 154, below anvil latching lever 160, as shown in FIGS. 8-10 .Transfer link 190 extends distal of actuator lobes 154 within the handle12. The opposite, unattached end of transfer link 190 includes twolaterally extending pins 192. Each laterally extending pin 192 engagesone of two transfer cam paths 194 formed into opposite sides of theinterior of handle casing 110. Each transfer pin 192 rides within campath 194, completing the full circuitous route as actuator 16 is twicesqueezed closed and reopened to deploy a staple. The movement oftransfer pin 192 about cam path 194 drives the advancing and retractingof the clamp and former during the staple deployment sequence. Cam path194 includes a series of four different steps or elevation changes totransition link 190 between the different stages in the deploymentsequence, as will be described in more detail below. Actuator 16includes cam surfaces 200 shaped into the distal faces of lobes 154.Actuator cams 200 are proximally spaced from but aligned to make contactwith the proximal face of clamp bushing 120 when the trigger grip 152 issqueezed towards pistol grip 14. A former lever 202 is mounted betweenformer bushing 112 and transfer link 190 to pivot about a pin 204 formedinto the handle casing 110. Former lever 202 includes a cam surface thatis longitudinally aligned with former bushing 112 to apply a distallydirected force to the bushing when the lever is pivoted in the distaldirection.

Actuator 16 pivots about a pin 210 that extends through actuator 16between trigger grip 152 and lobes 154. As shown in FIGS. 10 and 12 ,actuator 16 includes a handle lockout feature comprising a plurality ofratchet teeth, indicated at 212, ending in a distal release notch 214. Aspring-loaded pawl 216 is connected to the frame of pistol grip 14.Teeth 212 are angled to catch pawl 216 as the teeth move proximally overthe pawl. Pawl 216 engages successive ratchet teeth 212 as trigger grip152 is squeezed, to prevent a premature reopening of actuator 16 in theabsence of a squeezing force. As actuator 16 pivots to a fully-closedposition against pistol grip 14, teeth 212 move proximally beyond pawl216, pushing the pawl into release notch 214. At release notch 214, thetop of pawl 216 rotates clockwise against the angle of teeth 212,allowing the pawl to slide over the teeth back to a proximal-mostposition. A return spring 220 is connected between actuator 16 andpistol grip 14 for biasing the actuator into an open position. Returnspring 220 is connected so that the spring expands as actuator 16 issqueezed closed. Spring 220 returns actuator 16 to an open condition aspawl 216 reaches release notch 216, and the squeezing force on thetrigger grip 152 is released.

In the initial deployment position shown in FIGS. 12-14 , the upperlobes 154 of actuator 16 are in a proximal-most position, with anvillatching lever 160 in a proximal-most position engaging transfer wheel172. Anvil latch 184 is in a down position with the latch arm pushingagainst anvil stop 140 to hold the anvil in a distal-most position, asshown in FIG. 13 , in which anvil tines 56 extend outside distaldeployment opening 22. Proximal clamp latch 180 is also in a downwardposition in contact with the proximal end of clamp yoke 124 to holdclamp 60 in a forward position, inside deployment opening 22, andbeneath the distal-most staple in stack 70. Shoe side rails 88 push thedistal-most staple down against the upper surface of clamp 60, while thenext staple in stack 70 is held within C-channel 86 on the upper surfaceof the clamp. Clamp lockout spring 130 is positioned on the uppersurface of lockout tongue 131, as shown in FIG. 14 , and L-Latch 134 ispushed down by the distal end of clamp yoke 124. In this initialposition, transfer link 190 is also at a proximal-most position withintransfer cam path 194. Former lever 202 is pivoted away from formerbushing 112, allowing former return spring 114 to fully expand, andformer 50 to be retracted back proximally from anvil tines 56.

To deploy a staple 30, stapler 10 is inserted through a small diameterport or flexible endoscopic platform to reach the desired tissue areainside a body cavity. At the appropriate tissue location, stapler end 22is placed adjacent the tissue or tissue fold to be stapled, withrotating knob 90 being turned as necessary to position the staple prongs46. With stapler 30 appropriately positioned against the targeted tissuearea, trigger grip 152 is manually squeezed in the direction of pistolgrip 14 to begin the staple deployment sequence. As trigger grip 152 issqueezed actuator 16 pivots about pin 210, causing the upper lobes 154to pivot distally within the handle. The distally moving lobes 154 pullanvil latching lever 160 distally within anvil cam path 164. As latchinglever 160 moves distally, latching arm 170 pulls on the first transferwheel pawl, causing the wheel to rotate. As transfer wheel 172 rotates,the second pawl on the wheel begins to apply a downward force toproximal clamp latch 180. The downward force is initially insufficientto overcome clamp latch spring 182 and release clamp 60 back proximally.Simultaneously, the third transfer wheel pawl applies a proximal forceto the detent on anvil latch 184. The force on the anvil latch detentovercomes the force of anvil latch spring 186, pivoting the latch up andout of contact with anvil stop 140, as shown in FIG. 15 . As anvil latch184 pivots away from anvil stop 140, the anvil stop is released to moveproximally under the force of anvil spring 144, drawing anvil tines 56back inside of distal deployment opening 22 and against the distal clampface, as shown in FIG. 16 . Clamp 60 remains locked in position byproximal clamp latch 180, thereby preventing additional proximalmovement by anvil 52. As actuator lobes 154 pivot distally, transferlink 190 also begins to drive pin 192 distally up the first leg of campath 194, as shown in FIG. 17 .

As actuator lobes 154 continues pivoting distally, anvil lever 160 movesfurther distally within anvil cam path 164, rotating transfer wheel 172.The rotating wheel 172 applies increased force to the proximal end ofclamp latch 180, overcoming the force of clamp latch spring 182, andreleasing clamp yoke 124 to retract proximally under the force of clampreturn spring 122, as shown in FIG. 18 . Clamp yoke 124 draws clamp 60proximally until proximal clamp stop 132 bottoms out against the handleframe, as shown in FIG. 20 . Anvil 52 retracts proximally with the clamp60 until anvil stop 140 reaches the proximal end stop in the housingframe, as shown in FIGS. 18 and 20 . In this fully retracted position,the tip of clamp 60 is proximal of the distal-most staple in stack 70and anvil tines 56 are spaced distally forward of the clamp tip. Theretracted position of clamp 60 allows shoe 84 to push the distal-moststaple down into the discharge channel and over anvil tines 56, as shownin FIG. 19 . The proximal stop of clamp yoke 124 positions clamp bushing120 at the distal face of actuator cams 200.

The proximal movement of clamp yoke 124 also drives lockout spring 130up and over the proximal tip of lockout tongue 131, as shown in FIG. 20. As the lockout spring 130 drops below lockout tongue 131, the clamplockout member 128 resets inside clamp yoke 124, allowing the clamp yoketo advance beneath the adjoining frame of the housing casing duringsubsequent steps in the deployment sequence. In the event that actuator16 is moved very rapidly, the actuator cams 200 can, in some cases,prevent the clamp yoke 124 (and thus clamp 60) from fully retracting tothe proximal end stop. In this event, clamp 60 will remain forwardwithin the discharge channel and prevent the staged staple from droppingproperly into the channel. If the staged staple does not drop properlyinto the discharge channel, a staple jam can occur when the clamp 60advances distally. To prevent this possibility, lockout spring 130 willget held and fail to drop below lockout tongue 131 on the housing casingif the actuator 16 is moved too quickly. In this event, the lockoutspring 130 will keep the lockout member 128 lifted above the surface ofthe clamp yoke 124, thereby preventing the clamp yoke from advancingdistally beneath the adjoining section of the casing frame indicated at222. To reset the device for normal function, the user fully releasestrigger grip 152 to cause lockout spring 130 to drop below lockouttongue 131.

As actuator lobes 154 continue pivoting distally from the squeezingforce on trigger 152, cam surfaces 200 apply a distal driving forceagainst clamp bushing 120, as shown in FIG. 21 . The distal forceadvances clamp 60 through the discharge channel and into contact withstaple back span 32, as shown in FIG. 22 . As clamp 60 begins advancing,staple driving rod 74 rotates staple advancers 76 above the surface ofclamp extension 64. Staple advancers 76 push staple stack 70 distally asthe clamp advances. In addition, the movement of lobes 154 drivestransfer link 190 forward up the first leg of transfer cam path 194. Atthe proximal handle end, anvil latching lever 160 continues movingdistally along anvil cam path 164. Anvil latching arm 170 advancesdistally beyond the first pawl of transfer wheel 172, as shown in FIG.23 , disconnecting the lever 160 from the transfer wheel, and preventingfurther rotation of the wheel. The release of transfer wheel 172 allowsthe proximal end of clamp latch 180 to pivot downward under the force ofclamp latch spring 182. This positions the clamp latch 180 to engage theproximal face of clamp yoke 124 as the yoke advances distally beyond thelatch.

Actuator cams 200 continue pushing clamp bushing 120 distally againstthe force of clamp return spring 122, advancing clamp yoke 124, andallowing clamp latch 180 to pivot down behind the proximal end of theclamp yoke. The distal movement of lobes 154 drives transfer link 190within cam path 194, dropping the link pin 192 from the first to thesecond path leg as shown in FIGS. 24 and 26 . As clamp 60 advancesdistally within the discharge channel, the inward radius at the distalclamp tip engages the back span 32 of the staged staple and pushes thestaple against the proximal face of the anvil tines 56, holding thestaple back span fixed between the clamp and anvil tines. As actuator 16continues applying force to clamp bushing 120, clamp 60 drives thestaple 30 and anvil 52 forward through the open stapler end 22, as shownin FIG. 25 . As anvil tines 56 and the staged staple 30 progress throughthe distal stapler opening, the anvil tines remain inwardly biased,adjacent the intersection between the staple legs 34, 36 and back span32. With staple 30 held outside the open stapler end by clamp 60 andanvil tines 56, anvil stop 140 bottoms out against the handle casing, asshown in FIG. 27 , stopping further distal movement of anvil 52. Anvillatch 184 pivots down into contact with the proximal face of anvil stop140 to hold the anvil 52 forward outside the open stapler end.

When anvil 52 reaches its fully distal position, as shown in FIG. 28 ,the back span of staple 30 is firmly held between the tip of clamp 60and the proximal face of anvil tines 56. After anvil 52 reaches itsdistal stop, actuator 16 continues advancing clamp bushing 120 and,thus, clamp 60 relative to the fixed anvil tines. As clamp 60 advances,the clamp tip moves between anvil tines 56, pushing the tines outwardagainst the inside surfaces of staple 30 at the intersections betweenstaple legs 34, 36 and back span 32. The advancing clamp tip applies adistally directed force against staple back span 32 between anvil tines56. The distally directed force of clamp 60 drives the anvil arms outlaterally and deforms back span 32 between the anvil tines. Thedeforming force of clamp 60 against the fixed back span 32 drives theanvil tines 56 laterally into staple legs 34, 36, expanding open thestaple 30. As staple 30 is expanding open, staple legs 34, 36 are bentback against the distal angled face of clamp 60. The angle at whichstaple legs 34, 36 bend open can vary, depending in part upon the angleof the clamp distal tip. As staple 30 expands open from its initial,closed-form shape, prong tips 46 move from an inward, overlappingposition to the open, spread position described above, producing anincreased width dimension in the staple. The substantial increase inwidth between the closed, folded staple condition and the open, expandedstaple condition enables the staple to obtain a substantial tissuepurchase while utilizing a small diameter delivery shaft.

Clamp 60 opens staple 30 at the distal end of the clamp advancement. Atthis point, L-latch 134 springs up into engagement with clamp yoke 124to lock the clamp forward, with the staple pinned between the clamp andanvil tines. The transfer link 190 has advanced to the distal end of thesecond leg of the cam path 194, as shown in FIGS. 27 and 29 . The distaladvance of clamp yoke 124 has also pulled clamp lockout spring 130 backaround the distal end of the lockout tongue 131. As staple 30 expandsopen, actuator 16 pivots to a fully closed position, with lockout pawl216 advancing to release notch 214. At release notch 214, lockout pawl216 pivots free of the ratchet teeth 212, allowing actuator 16 to pivotopen under the force of actuator return spring 220. As actuator 16reopens, transfer link 190 is drawn back down the second leg of cam path194. A step between the first and second cam path legs prevents link pin192 from reversing back into the first leg of the path. At the proximalend of the second cam path leg, the transfer link pin 192 drops overanother step into the proximal end of the third path leg, as shown inFIGS. 30 and 32 . At this point in the deployment sequence, actuator 16does not return to the fully open, initial position due to the moreproximal location of the transfer link pin 192 in the cam path 194.Anvil link pin 162 retracts within anvil cam path 164 as actuator 16pivots open. However, because the actuator 16 does not return to thefully open, initial position, latching arm 170 and transfer wheel 172remain disconnected. With staple 30 fully expanded and stabilizedbetween clamp 60 and anvil tines 56, as shown in FIG. 31 , the releaseof actuator 16 provides a pause in the deployment process to allow thesurgeon to manipulate the open, exposed staple 30 to pierce or otherwiseengage the intended tissue.

After the prongs 46 of the expanded staple 30 have been inserted at thedesired tissue locations, the staple is formed through the tissue byagain applying squeezing pressure to trigger grip 152. The pressure ongrip 152 pivots actuator 16, causing transfer link 190 to advancedistally within the third leg of transfer cam path 194. As link 190advances distally, the link applies force against the former lever 202,which in turn pushes against former bushing 112, as shown in FIGS. 33and 35 . The force of transfer link 190 drives the bushing 112 forward,compressing former return spring 114. Former bushing 112 pushes housing20 distally relative to the fixed staple deploying assembly, with slot87 sliding past guide key 78 as the housing advances relative to thefixed staple guide 82. Housing 20 moves former 50 distally, drawinggrooves at the distal end of the former against the expanded staple legs34, 36. The expanded staple is held fixed relative to the moving former50 by clamp 60 and anvil tines 56. The distal pushing force of former 50against the expanded staple legs 34, 36 forces the legs to bend forwardabout the fixed anvil tines 56, closing the staple, as shown in FIG. 34.

In the finished, closed shape, the width of the staple is greater thanthe previous, undeployed width, due to the different bending pointsalong the staple length. This change in staple width enables the stapleto have a low profile during delivery and a larger profile when formedthrough tissue. As staple legs 34, 36 are bending forward, prongs 46 aredrawn back inward, grabbing onto the tissue or material in the spreadbetween the prongs. As prongs 46 move inward, staple ends 40, 42traverse an arc through the tissue, drawing the tissue into the closingstaple. As prongs 46 reach an inward, preferably overlapping position,in which the staple 30 passes through the gripped tissue, former 50reaches its distal-most position. Inside handle 12, handle lockout pawl216 advances over ratchet teeth 212, preventing distal movement offormer 50 until the former is in a distal-most position, as shown inFIG. 35 . At the distal-most position, lockout pawl 216 reaches releasenotch 214, enabling actuator 16 to pivot back open under the force ofreturn spring 220.

As actuator 16 pivots open, as shown in FIGS. 36 and 38 , actuator lobes154 rotate back, pulling transfer link 190 back proximally, and droppinglink pin 192 from the third to the fourth leg of transfer cam path 194.As transfer link 190 moves proximally, the force against former lever202 is removed, allowing the lever and former bushing 112 to retractproximally from the release of compression in former return spring 114.As former 50 retracts, key 78 moves to the distal end of housing slot87, and former 50 is drawn away from the closed staple 30, as shown inFIG. 37 , releasing the staple from the former. As transfer link 190continues moving back proximally through the fourth leg of cam path 194,the link pushes against the distal angled face of clamp L-latch 134, asshown in FIG. 36 . The contact with L-latch 134 pushes the latch downfrom clamp yoke 124, as shown in FIG. 38 . Clamp yoke 124 then retractsback into contact with proximal clamp latch 180, pulling clamp 60 backproximally inside former 50. As clamp 60 retracts, control pin 80rotates staple advancers 76 down into clamp extension trough 72. Thestaple advancers 76 retract back beneath the staple stack 70, leavingthe stack in a distally indexed condition. Staple guide arms 83 hold theindividual staples in stack 70 distally as the clamp extension retractsbeneath the staples. As clamp 60 retracts proximally, the anvil armsretract back inward within the closed staple 30, releasing the pressureof anvil tines 56 against staple legs 34, 36. The formed staple 30remains locked in the tissue (not shown), and held against anvil tines56 outside the open stapler end 22. With the anvil arms retracted,staple 30 can be released from the stapler by maneuvering the anvil 52away from the staple. As actuator 16 pivots fully open, transfer linkpin 192 reaches the proximal end of the transfer cam path 190, resettingthe transfer link back to the initial deployment position shown in FIGS.12 and 14 . Actuator 16 opens fully to the initial deployment position,and the stapler 10 resets back to the initial deployment condition, withthe distal-most staple in stack 70 again staged between shoe side rails88 and clamp 60 in preparation for the next deployment sequence.

If anvil tines 56 retract back inside former 50 before staple 30 isreleased, the anvil 52 can be pushed out distally by inserting a forcepsor similar tool into the proximal handle opening 150. Through opening150, the forceps can push against anvil release member 142 to driveanvil stop 140 distally. Release member 142 can be pushed until anvilstop 140 is again locked forward by anvil latch 184, to hold the anviltines 56 outside the open end 22 of the stapler.

After the staple 30 is released from anvil 52, stapler 10 is preferablymoved to a second targeted location along an intended fold line in acavity wall or tissue apposition. Additional staples are preferablydeployed along the cavity wall to extend the length of the fold.Additional details regarding GVR procedures and the use of a staplingdevice, such as the staple deploying device of the present invention, ina GVR procedure; as well as other surgical applications for the staplingdevice of the present invention, can be found in commonly assigned U.S.patent application Ser. No. 12/359,351, which was previouslyincorporated by reference into this application.

To complete the laparoscopic greater curvature plication (LGCP)procedure described in the previously referenced article by Brethauer etal. with this device, it is envisioned that this device should be ableto fire at least forty staples without the need for reloading thedevice. It is also conceived that such a device may be used for otherapplications and would be able to fire at least twenty staples withoutthe need for reloading the device. For LGCP it is conceived that anoptimal procedure would comprise the following steps. The patient shouldbe placed in the supine position. A five trocar port technique isutilized. In most cases, five 5-mm ports are placed. A Veress needletechnique or Hassan technique can be utilized to establishpneumoperitoneum. A 5-mm trocar is placed above the umbilicus andslightly to the right of midline. The laparoscope is inserted and theabdomen is inspected. Trocars are then placed in the following locationsunder direct visualization: a 5-mm trocar in the right upper quadrant, a5-mm trocar in the right upper quadrant below the 10-mm trocar at theaxillary line, a 5-mm trocar below the xiphoid appendices, and a 5-mmtrocar in the left upper quadrant. Percutaneous graspers andmagnetically guided camera systems may be used to reduce the number oftrocars used in this procedure. The greater curvature is then freed fromits attachment points. The dissection starts at the distal body of thestomach along the greater curvature and continues proximally to theAngle of His. The left crus should be seen and the fundus mobilized offof the left crus. The dissection is then continued distally along thegreater curvature to within 4-6 cm of the pylorus. Posterior gastricadhesions can be taken down as needed. Care should be taken to ensurethat the dissection occurs approximately 0.5-1.0 cm from the greatercurvature to avoid thermal damage to the gastric wall. The plication isideally comprised of at least two rows of staples. To create the firstrow, an endoscope or bougie in place for sizing and the greatercurvature is imbricated from the angle of His to within 4-6 cm of thepylorus. Approximately 10 staples should be used in this row with thespacing between staples kept at approximately 2-3 cm. The first stapleis placed approximately 2 cm from the Angle of His. When creatingplications, care must be taken not to obstruct at the EG junction andthe angularis incisura as these are the two most common sites ofobstruction. Intraoperative endoscopy, bougies with features, pressurebased measurement systems, etc. may be used to aid in the sizing of theplication during its formation. To create the second row, the process isrepeated starting near the Angle of His and extending the plicationabout the first row to the vicinity of the pylorus. As this second rowis intended to be the final row, the spacing between staples should beno more than 1 cm. It is conceived that approximately 30 staples shouldbe in this row for an average sized human stomach. A leak test withmethylene blue can be performed or an insufflations test with theendoscope can be used to check for a leak.

Figures from the previously referenced article by Menchaca et al.disclose different fastener patterns for creating durable plications ina canine model. They present data on a range of patterns, fasteners, andsurface pretreatments. They show two histology images showing thedifferences between plications created with sutures using differentpatterns. FIG. 39 shows a histologic image from Menchaca et al. whereinthe plication was formed with multiple rows of suture resulting in adurable plication. In FIG. 39 , arrows 390 point to spaces with suture.The internal tunica muscularis 392 is denoted by the region containingthe letter ‘M’. The external tunica muscularis 394 is denoted by theregion containing the letter ‘m’. The serosal surfaces have beenreplaced with a dense collagenous scar 396 denoted by the regioncontaining the letter ‘S’. FIG. 40 shows a second histologic image fromMenchaca et al. In FIG. 40 , fibrous healing 400 of the plication isevident on the exterior (serosal) surface of the stomach. The mucosa 404is denoted by the region containing the letter ‘M’. The submucosa 406 isdenoted by the region containing the letters ‘SM’. The tunica muscularis408 is denoted by the region containing the letters ‘TM’. In contrast toFIG. 39 serosal space 402 is present within the region of the fold. Theplication in FIG. 40 was formed with a single row of suture in aninterrupted pattern. They state that “Intermittent point failures inserosal apposition occurred in those dogs that had received only 1 rowof fasteners; in regions of the fold not containing fasteners, theserosal surfaces had not bonded”. FIG. 41 shows an unpublishedhistologic image from a similar study performed with the devicedescribed in this application. In FIG. 41 the histologic image shows thefolded gastric wall is fused together by chronic inflammation/fibrosis410 denoted by the region containing the letter ‘F’ at the base of thefold (base of the pre-existing serosa). In this study, three rows ofstaples were used to create a plication in a canine model. The innerrows had a coarse (2-3 cm) spacing as described above whereas theoutermost row was comprised of staples having an approximately 1 cmspacing. As such, aside from the region of fibrosis 410 whichcorresponds to the outermost or final row of staples, there are twoareas of serosal fusion 412 in the fold denoted by the regionscontaining the letter ‘S’. Regions of the fold remained unboundedbetween rows resulting in free space 414, but no intermittent pointfailures were observed. Thus the pattern described above is uniquelymore durable than that described in Menchaca et al. Further, that thisdurability was achieved with the presence of free space between the rowsallows for easier reversal of this procedure as tissue dissection planesare easily identified. This is a significant advantage noted bypotential patients of this procedure or any other bariatric surgicalprocedure. Applying an approximate spacing of 1 cm along a significantportion of the greater curvature of the stomach with a sutured patternrequires significant time and skill. The described device when used withthe pattern described (e.g., at a minimum employing at least one rowwith approximately 1 cm spacing on the outermost row) provides uniqueand unforeseen advantages over existing technology. A durable plicationcan be created quickly and easily, without point failures, whileresulting in the presence of free space facilitating easier reversalwith standard laparoscopic techniques.

Preferably, the invention described herein will be processed beforesurgery. First, a new or used instrument is obtained and if necessarycleaned. The instrument can then be sterilized. In one sterilizationtechnique, the instrument is placed in a closed and sealed container,such as a plastic or TYVEK bag. The container and instrument are thenplaced in a field of radiation that can penetrate the container, such asgamma radiation, x-rays, ethylene oxide (EtO) gas, or high-energyelectrons. The radiation kills bacteria on the instrument and in thecontainer. The sterilized instrument can then be stored in the sterilecontainer. The sealed container keeps the instrument sterile until it isopened in the medical facility.

In addition to reconditioning, stapler 10 of the present invention mayalso be reloaded with an additional stack of staples for use in multipledifferent surgical procedures. To reload the stapler, the distal end 94of the staple housing is unscrewed from castle nut 100. Housing 20 isremoved to expose the inner components of the staple deploying assembly.Staple guide 82 and clamp extension 64 are then separated and a newstaple stack 70 laid in position between the two parts. After the stackof staples is loaded, the staple guide and clamp extension arerepositioned on opposite planar surfaces of the stack. The staplehousing 20 is then slid back over the staple deploying assembly andreattached at the proximal end to castle nut 100. Staple housing 20 canbe adjusted via castle nut 100, as described above, to obtain theoptimal staple housing length for opening and forming staples duringdeployment.

Any patent, publication, application or other disclosure material, inwhole or in part, that is said to be incorporated by reference herein isincorporated herein only to the extent that the incorporated materialsdoes not conflict with existing definitions, statements, or otherdisclosure material set forth in this disclosure. As such, and to theextent necessary, the disclosure as explicitly set forth hereinsupersedes any conflicting material incorporated herein by reference.Any material, or portion thereof, that is said to be incorporated byreference herein, but which conflicts with existing definitions,statements, or other disclosure material set forth herein will only beincorporated to the extent that no conflict arises between thatincorporated material and the existing disclosure material.

The foregoing description of preferred embodiments of the invention hasbeen presented for purposes of illustration and description. It is notintended to be exhaustive or to limit the invention to the precise formdisclosed. Obvious modifications or variations are possible in light ofthe above teachings. The embodiments were chosen and described in orderto best illustrate the principles of the invention and its practicalapplication to thereby enable one of ordinary skill in the art to bestutilize the invention in various embodiments and with variousmodifications as are suited to the particular use contemplated. It isintended that the scope of the invention be defined by the claimsappended hereto.

What is claimed is:
 1. A surgical fastener comprising: a base, and two legs extending away from said base, said legs having distal end segments; said fastener having a first shape wherein said distal end segments bend towards and across each other so that they are adjacent, contiguous and contacting each other along substantially an entire length of said end segments and thereby form said fastener into a first closed-form loop; said fastener having a second shape wherein said distal end segments are spaced apart from each other along substantially an entire length thereof; said fastener having a third shape wherein said distal end segments bend towards each other in so that they are adjacent and form said fastener into a second loop, said second loop having a width greater than a width of said first loop; wherein the fastener transitions from the first shape to the second shape and from the second shape to the third shape.
 2. The surgical fastener of claim 1 wherein said legs in said first shape extend from said base in a substantial parallel relationship.
 3. The surgical fastener of claim 1 wherein said distal end segments are angled away from said base at least 90 degrees.
 4. The surgical fastener of claim 1 wherein said first loop is asymmetric about all planes perpendicular to an axis along a length of said loop.
 5. The surgical fastener of claim 1 wherein said base of said first loop is non-linear.
 6. The surgical fastener of claim 1 wherein said base of said second loop is plastically deformed.
 7. The surgical fastener of claim 1 wherein said base of said second loop is non-linear.
 8. The surgical fastener of claim 1 wherein at least a portion of said fastener is absorbable.
 9. The surgical fastener of claim 1 wherein at least a portion of said fastener contains a therapeutic agent. 